Alan Poole
European Centre for Ecotoxicology & Toxicology of Chemicals, Belgium
Title: Guidance on the selection of cohorts for extended one-generation reproduction toxicity study (OECD 443)
Biography
Biography: Alan Poole
Abstract
The extended one-generation reproduction toxicity study (EOGRTS; OECD test guideline 433) is a new and technically complex design to evaluate the putative eff ects of chemicals on fertility and development, including eff ects upon the developing nervous and immune systems. In addition to off ering a more comprehensive assessment of developmental toxicity, the EOGRTS provides important improvements in animal welfare through reduction and refi nement of use of experimental rodents in a modular study design. The challenge to the practitioner however is to know how the modular aspects of the study should be triggered on the basis of prior knowledge of a particular chemical, or on earlier fi ndings in the EOGRTS itself, requirements of specific regulatory frameworks not withstanding. Th e purpose of this document is to offer guidance on science-based triggers for these extended evaluations.
